Kornimate/medical-research-clean huggingface dataset:
the effect of stimulating substances on brain activity of preterm infants

Conditions: Apneas of Prematurity

Summary: introduction: methylxanthines and doxapram have been widely used for the treatment of apneas of prematurity. both substances have effects on the central nervous system. while there are data available concerning the use of caffeine (the methylxanthine used at our nicu) even proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are data which suggest a negative effect of the central stimulants doxapram on longterm outcome in this group of infants. nevertheless concerning both medications only few studies have been published and only scarce data are available concerning the effect of these medications on brain activity of very preterm infants until now. the aim of this study: is the assessment of the effect of stimulating substances on brain activity of preterm infants born below 30 weeks of gestation and their longterm neurodevelopmental follow-up. methods: this study is a prospective study including preterm infants born below 30 weeks of gestational age. brain activity is measured by one-channel amplitude-integrated eeg (aeeg). the first aeeg measurement is performed without caffeine and/or doxapram medication. at least one hour of brain activity is registrated. the second measurement is done at least 24 hours after the start of caffeine and/ or doxapram treatment. the percentage of different background patterns, the occurrence and duration of sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed. neurodevelopmental outcome is assessed at one and two years of corrected age by assessment of the bayley scales of infant development ii and standardized clinical neurological examination.


Eligibility criteria:
inclusion criteria: see above exclusion criteria: * intraventricular hemorrhage * posthaemorrhagic hydrocephalus * cerebral infection * cerebral malformation
propofol versus sevoflurane anesthesia in pediatric strabismus surgery: feasibility of bis monitoring

Conditions: Strabismus

Summary: this study is conducted to evaluate importance of bispectral index (bis) monitoring in patients undergoing strabismus surgery when using propofol in comparison to sevoflurane anesthesia regarding their effects on oculocardiac reflex, intraoperative hemodynamic stability, emergence agitation, postoperative pain, nausea and vomiting.

strabismus surgery can cause unfavorable side effects during intraoperative and postoperative periods including increased risk of the oculocardiac reflex, hemodynamic instability, emergence agitation, postoperative pain, nausea and vomiting. sevoflurane is an inhalation anesthetic widely used in pediatric anesthesia with minimal airway irritation. propofol is an intravenous sedative-hypnotic agent with amnestic properties that causes loss of consciousness. bispectral index monitor provide some more evidence that deeper anesthesia can provide some protection against the oculocardiac reflex. therefore, this study is conducted to evaluate the role of bis monitoring in comparing the use of propofol and sevoflurane anesthesia in pediatric strabismus surgery. this prospective, randomized, comparative clinical study will include 100 children who are scheduled for elective strabismus surgery under general anesthesia in mansoura ophthalmology center. informed written consent is obtained from parents of all subjects in the study after ensuring confidentiality. the study protocol is explained to parents of all patients in the study who are kept fasting prior to surgery. patients are randomly assigned to two equal groups according to computer-generated table of random numbers using the permuted block randomization method. the collected data are coded, processed, and analyzed using spss program. all data are considered statistically significant if p value is ≤ 0.05.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology (asa) i and ii patients. * scheduled for elective strabismus surgery. exclusion criteria: * parental refusal of consent. * hyperactive airway disease or respiratory diseases. * children with developmental delays, mental or neurological disorders. * bleeding or coagulation diathesis. * history of known sensitivity to the used anesthetics. * children with previous surgery in the eye.

Keywords: bispectral index monitoring
validation of questionnaire in retinal degeneration

Conditions: Retinal Degeneration

Summary: while inherited retinal diseases are well characterized anatomically and functionally, it is also essential to understand their impact on patients' quality of life, from their ability to perform the tasks of daily living to the psychological impact of the disease on patients. questionnaires (pro, patient-reported outcomes) are important tools for assessing this impact. however, pros validated in french are rare, and often poorly adapted to populations with hereditary retinal degeneration. new pros particularly adapted to retinal degeneration have recently been validated in english: the michigan retinal degeneration questionnaire (mrdq) and the michigan vision-related anxiety questionnaire (mvaq). validation of a french translation will provide a standardized, reliable tool for french-speaking patients, and enable these questionnaires to be used in gene therapy clinical trials, to assess the efficacy of treatments and their impact on patients' quality of life.

interventional research of category 2 with minimal risks and constraints. this is a prospective, monocentric, longitudinal, non-randomized study to validate the translation of questionnaires to assess abilities in daily living tasks and the potential psychological repercussions of visual impairment in various hereditary retinal dystrophies. the research will be conducted in two distinct phases: comprehension phase and validation phase

Eligibility criteria:
inclusion criteria: * male or female * age: 18 to 80 * sufficient knowledge of the french language to ensure understanding of the tasks to be performed and the instructions received. * signed consent after being informed by the investigator. * affiliation with health insurance. * affected by one of the following rare pathologies, with different levels of visual field, acuity and contrast sensitivity impairment: * non-syndromic rod-cone dystrophy (retinopathy pigmentosa, rp): diagnosis confirmed by a specialist. * non-syndromic rod-cone dystrophy: diagnosis confirmed by a specialist. * non-syndromic stargardt's disease: diagnosis confirmed by a specialist. * non-syndromic congenital night blindness: diagnosis confirmed by a specialist. * non-syndromic achromatopsia: diagnosis confirmed by a specialist. exclusion criteria: * pregnancy * inability to give informed consent. * cataract surgery within 3 months of inclusion. * hearing impairment that may interfere with comprehension during the interview. * functional amblyopia. * inability to comply with instructions to perform study tasks or study visits. * drug treatment that may cause motor, visual or cognitive impairment (psas, neuroleptics, etc.) or that may interfere with study assessments. * other uncontrolled ophthalmic conditions that may interfere with evaluation. * participation in another clinical trial that may interfere with the present study. * patient under guardianship, curatorship or legal protection
mild hypothermia influence on patient outcome in major abdominal surgery

Conditions: Surgical Site Infection; Bleeding

Summary: this study investigate associations between mild hypothermia (patients' core temperature ≤ 36.0 degrees celsius) and intra-operative blood loss and surgical site infections (ssi) in patients undergoing major abdominal surgery.

this study evaluates associations between patients' core temperature during surgery and intra-operative blood loss, and to ssi. additionally, the investigators observe the use of hypothermia prevention measures in operating theaters, use of surgical safety checklists. ssi is registered at discharge from hospital and up to 30 days post-discharge. the goal of the study is to contribute to focus on prevention of even mild hypothermia in surgery. this study is of interest for healthcare personnel as operating room nurses, surgeons, nurse anaesthetists, anaesthesiologists, ward nurses, post anaesthetic care unit nurses, and other healthcare staff involved in the in-hospital surgical pathway.

Eligibility criteria:
inclusion criteria: * patients (men or women) above 18 years, undergoing abdominal or gynecological surgery with laparotomy or laparoscopy. exclusion criteria: * surgical procedures with intentional reduction of core temperature. patients under the age of 18.

Keywords: surgery hypothermia prevention surgical site infection bleeding surgical instruments
immunogenicity & safety study of a meningococcal serogroup b vaccine given in a 3 dose schedule to healthy adolescents aged 12-18 yrs

Conditions: Infections, Meningococcal

Summary: the purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup b vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of havrix™ (0-6 months) and meningitec™ (month 1).

the study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses.

Eligibility criteria:
inclusion criteria: * healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination. * female subjects must be of non-childbearing potential. exclusion criteria: * previous vaccination against or history of meningococcal b or c, or hepatitis a disease or exposure to meningococcal b disease within last year. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * family history of congenital or hereditary immunodeficiency. * history of any neurologic disorders or seizures.

Keywords: prophylaxis meningococcal serogroup b disease
regional distribution of ventilation to assess respiratory muscle dysfunction

Conditions: Respiratory Failure; Neuromuscular Disorder; Diaphragmatic Paralysis

Summary: the aim of this study is to better discriminate respiratory muscle dysfunction by comparing the measurements of thoracoabdominal motion obtained by an optoelectronic recording and the conventional tests of respiratory muscle strength. the final objective is to better select in the future the patients who need more specific assessment of diaphragmatic function like "maximal transdiaphragmatic pressure" measurement and "phrenic nerve stimulation".

all patients which had suspected respiratory muscle dysfunction will have usual exploration of the respiratory muscles according to the clinician prescription. these explorations can include : * lung volumes in seating and supine position * maximal inspiratory and expiratory pressures * maximal sniff pressures and when diaphragmatic dysfunction is suspected : * maximal transdiaphragmatic pressure * phrenic nerve conduction these patients will also beneficiate to the determination of volume variations of the upper rib cage, the lower rib cage and the abdominal compartments by using opto-electronic plethysmography.

Eligibility criteria:
inclusion criteria: * suspicion of respiratory muscle dysfunction * indication of diaphragm exploration exclusion criteria: * acute respiratory failure

Keywords: diaphragm abdomen breathing pattern dyspnea
to evaluate the optimal dose of 68ga-ops202 as a pet (positron emission tomography) imaging agent in subjects with gastroenteropancreatic neuroendocrine tumour (gep-net)

Conditions: Gastro-Enteropancreatic Neuroendocrine Tumor

Summary: the purpose of this clinical research is to confirm the optimal dose of 68ga-satoreotide trizoxetan (68ga-ipn01070), formerly 68ga-ops202, as a pet imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (gep-nets). 68ga-ipn01070 is a radiolabelled imaging agent to be used in association with positron-emission-tomography (pet). 68ga-ipn01070 is made of two main components: 1) ipn01070, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) gallium-68, a radioisotope that combined with ipn01070 can be seen in the pet scanner.


Eligibility criteria:
inclusion criteria: * pathologically confirmed, well differentiated functioning or non-functioning metastatic gep-net (grade i and ii as per world health organisation classification 2010) * confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive somatostatin receptor scan acquired within 6 months prior to screening (visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility * body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive * adequate bone marrow, liver and renal function * eastern cooperative oncology group (ecog) performance status ≤2 exclusion criteria: * fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs * subject who have received treatment of any somatostatin analogue, including somatuline® autogel® /depot®, sandostatin® lar within 28 days, and sandostatin® within 24 hours prior to first 68ga-ops202 administration * prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide * any condition that precludes the proper performance of pet and/or ct scan: a) subjects who are not able to tolerate the ct contrast agent, b) subjects with metal implants or arthroplasty, or any other objects that might interfere with the pet and/or ct analysis, c) subjects unable to raise arms for prolonged imaging purposes, d) subjects unable to lie still for the entire imaging time, e) subjects weighing greater than 110 kg (243 lb)
olanzapine or dexamethasone, with 5-ht3 ra and nk-1 ra, to prevent cinv

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. however, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns. several clinical trials have shown that olanzapine plays an important role in treating delayed, refractory, breakthrough nausea and vomiting. its side effects mainly include sedation and weight gaining. at present, the nccn guidelines have recommended olanzapine-containing three-drug regimen for highly emetogenic chemotherapy (hec) and moderate emetic chemotherapy (mec) to prevent vomiting, but its data in the chinese population is limited. hence, we initiated this prospective, multi-center, phase iii study to validate the dexamethasone-free protocol: applying olanzapine to prevent cinv instead of dexamethasone.


Eligibility criteria:
inclusion criteria (patients are eligible to be included in the study only if they meet all of the following criteria): 1. cancer patients, age ≥ 18 years and ≤75 years, ecog score 0-2 points, receiving cisplatin-containing doublet chemotherapy such as cisplatin + gemcitabine / albumin paclitaxel / etoposide /fluorouracil / irinotecan / temozolomide as first line treatment; 2. life expectancy ≥ 3 months; 3. leucocytes≥3,000/ul; 4. ast≤2.5 × upper limit of normal; 5. bilirubin ≤1.5 × upper limit of normal; 6. serum creatinine ≤ 1.5 × upper limit of normal. exclusion criteria (patients will be excluded if any of the following criteria is met): 1. history of cns disease, such as brain metastases or epilepsy; 2. use of other antipsychotic drugs (such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, or such treatment is under scheduling during the study) within 30 days before enrollment; long-term use of phenothiazine as an antipsychotic agent; 3. concurrent use of pharyngeal or abdominal radiotherapy; 4. concurrent use of quinolone antibiotics; 5. chronic alcoholism; 6. known hypersensitivity to olanzapine; 7. know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months; 8. known uncontrolled diabetes mellitus; 9. vomiting or retching 24 hours before chemotherapy; 10. use of anti-emesis drugs 48 hours before chemotherapy; 11. concurrent use of amifostine; 12. concurrent use of corticosteroids and the only anti-allergic choice is corticosteroids

Keywords: nausea vomiting antiemesis
prediction of clinical response and outcome in uterine cervix cancer

Conditions: Cervix Cancer

Summary: observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. the study hypothesis is that data extracted form fdg-petct used in the routine clinical practice can predict outcomes following standard treatment.

this study will prospectively collect patients undergoing to the standard diagnostic and treatment protocol in maastro clinic. any difference in the normal procedure will be adopted. the aim is to extrapolate form the pet images some features of the metabolic tumor activity to associate with different outcomes and tumor behaviours.

Eligibility criteria:
inclusion criteria: * histologically confirmed cervix carcinoma (all subtypes) * tumor stages figo ib - iva * scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia) * pre treatment fdg petct * the patient is willing and capable to comply with study procedures * 18 years or older * written informed consent to the treatment exclusion criteria: * recent (\< 3 months) myocardial infarction * uncontrolled infectious disease * pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study * previous surgery to the cervix * previous radiation to the cervix

Keywords: cervix cancer suv radiotherapy outcome prediction imaging pet
prospective study of video-assisted rib planting in chest wall stabilization

Conditions: Rib Fractures; Rib Fracture Multiple

Summary: the purpose of this study is to compare the advantages and disadvantages of video-assisted rib planting and traditional internal fixation of rib fractures in chest wall stabilization. the investigators design a new surgical method of video-assisted thoracoscopic surgery for rib fractures, evaluate the advantages and disadvantages of the new surgical techniques with a prospective study.


Eligibility criteria:
inclusion criteria: -≥3 unilateral rib displacement fractures * 18-70 years old * asa score i-ii * preoperative arterial oxygen partial pressure \>60mmhg * carbon dioxide partial pressure \<50mmhg exclusion criteria: * the distance from the broken end of the posterior rib fracture to the spine is less than 2cm * airway stenosis * abnormal coagulation system * history of peptic ulcer or bleeding * history of allergy to anesthesia related drugs * history of asthma or chronic obstructive pulmonary emphysema * pregnant women

Keywords: internal fixation video-assisted chest wall stabilization prospective study
effectiveness of selegiline in treating marijuana dependent individuals - 1

Conditions: Marijuana Abuse

Summary: during the past 15 years, the demand for treatment for marijuana-related problems in the united states has increased nearly twofold. selegiline is a medication currently used to treat nicotine dependence. the purpose of this study is to evaluate whether selegiline may be useful in treating individuals with marijuana dependence.

behavioral therapy paired with drug therapy might be a more effective treatment approach to marijuana dependence than behavioral therapy alone. selegiline is a monoamine oxidase-b inhibitor. it increases dopamine activity in parts of the brain that are involved in dependence on addictive drugs such as nicotine, cocaine, and marijuana. selegiline has been effective in treating nicotine dependence, but has not yet been studied in treating marijuana dependent individuals. the purpose of this study is to evaluate the effectiveness of selegiline in treating marijuana dependent individuals. specifically, this study will determine whether selegiline reduces marijuana craving and withdrawal symptoms, thus leading to reduction or abstinence in marijuana use. participants in this 9-week, double-blind, placebo-controlled study will be randomly assigned to receive either selegiline (10 mg/day in two 5 mg pills) or placebo. study visits will occur twice each week. at each study visit, participants will complete self-reports and urine toxicology tests. throughout the study, participants will receive weekly individual counseling. the counseling sessions will last 15 minutes. reduction in marijuana use as well as the number of weeks of consecutive marijuana abstinence will be evaluated.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for current marijuana dependence * positive urine toxicology test for marijuana * reports current marijuana use * weighs at least 100 lbs * women of childbearing age will be included provided they agree to use adequate contraception exclusion criteria: * meets dependence or abuse criteria for alcohol * meets dependence criteria for illicit substances other than marijuana * serious medical disorders (such as unstable angina or liver failure), that may make participation in the trial unsafe * pregnant * currently diagnosed with a psychotic disorder * currently suicidal or pose a homicidal risk * currently taking over-the-counter (e.g., pseudoephedrine) or prescription (e.g., methylphenidate) sympathomimetic agents, antidepressant agents (e.g., tricyclic antidepressants, serotonin reuptake inhibitors, bupropion, other monoamine oxidase inhibitors), or meperidine (demerol) * unable to understand english * known hypersensitivity to selegiline hydrochloride

Keywords: cannabis use disorder